Director, Technical Services Manufacturing Science

Functions, Duties, Tasks

• Ensure that the technical competencies/knowledge for the site’s monoclonal antibody processes, raw materials, sterile processes, and primary packaging components are in place (as applicable).
• Advises, guides and coaches TSMS associates for the purpose of ensuring routine operational support, identifying solutions and improvement, solving problems, decision making and communication including quality of written reports.
• Ensures adherence to cGMP requirements, guidelines, SOPs, as well as compliance to local laws, the Elanco Red Book, company policies and Health Safety & Environment (HSE) requirements.
• Ensure that mAb products and processes are in control and capable, with appropriate control strategies in place to meet Elanco Global Quality and Manufacturing standards and maintain continuity of supply.
• Develop and lead continuous improvement initiatives which positively impact cycle time, productivity, process robustness, gross margin, and production capacity.
• Partner with Commercialization, R&D, Manufacturing, Engineering, Supply Chain and Quality to successfully in-transfer new mAb products.
• Leads cross functional teams for root cause investigations.
• Drives the product control strategy including development and application of KPIs to enable meaningful CPP/CQA trending and reporting of key process data.
• Develop the expense and capital planning budgets for the TSMS function in collaboration with the Sr. Director, Commercialization and site leadership team.
• Responsible for the design and delivery of TSMS owned technical training programs as well as appropriate technical on-boarding to ensure competency of TSMS associates.
• Build and grow the TSMS function, recruiting and developing talent in alignment with the site’s strategic needs.
• Maintain a safe work environment and establish a strong safety culture in compliance with Elanco standards and all applicable government requirements.
• Accountable for quality performance of the function and delivery against site quality targets.
• Develop and review operational objectives with direct reports, establish appropriate talent development plans, and conduct staff performance management reviews as required.

Minimum Qualification

• Bachelor’s degree in a biomanufacturing related discipline (e.g. biology, Chemistry, engineering, etc.).
• 10 years of related working experience
• 5+ years’ experience in technical management position.
• 5+ years’ experience in (bio)pharmaceutical formulation, process development, or manufacturing technology.
• Ability to lead and develop a team.
• Fundamental understanding of (bio)pharmaceutical analytical testing.
• Demonstrated understanding of Q culture, cGMP standards, and regulatory regulations.

Additional Preferences

• MSc in Science, Pharmacy, Mechanical or Chemical Engineering, Pharmaceutical Technology.
• Proficiency in applied statistics/Lean Six Sigma methodologies.
• Understanding of USDA, FDA, and EU GMP regulatory standards for veterinary biologics.
• Demonstrated problem solving experience, identifying and understand issues, problems, and opportunities.
• Ability to network and build strong, collaborative relationships across functions / geographies.
• Excellent verbal and written communication skills (English).
• Strong mentoring and coaching skills